ESOMEPRAZOLE tablet, orally disintegrating, delayed release

Esomeprazole by

Drug Labeling and Warnings

Esomeprazole by is a Otc medication manufactured, distributed, or labeled by Dexcel Pharma Technologies Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Esomeprazole 20 mg

(Each delayed-release tablet corresponds to 22.3 mg

esomeprazole magnesium trihydrate) 

Purpose

Acid reducer 

Uses

•  treats frequent heartburn (occurs 2 or more days a week)
•  not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

Allergy alert: Do not use if you are allergic to esomeprazole

• Esomeprazole may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use if you have:

• trouble or pain swallowing food, vomiting with blood, or bloody or black stools
• heartburn with lightheadedness, sweating or dizziness
• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• frequent chest pain

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

• had heartburn over 3 months. This may be a sign of a more serious condition.
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting  
• stomach pain

Ask a doctor or pharmacist before use if you are

• taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

• your heartburn continues or worsens
• you need to take this product for more than 14 days
• you need to take more than 1 course of treatment every 4 months
• you get diarrhea
• you develop a rash or joint pain 

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• adults 18 years of age and older
• this product is to be used once a day (every 24 hours), every day for 14 days
• may take 1 to 4 days for full effect

14-Day Course of Treatment

• take 1 tablet before eating in the morning
• do not crush or chew tablets
• place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
• take every day for 14 days
• do not take more than 1 tablet a day
• do not use for more than 14 days unless directed by your doctor
• do not take this medicine with alcohol

Repeated 14-Day Courses (if needed)

• you may repeat a 14-day course every 4 months
• do not take for more than 14 days or more often than every 4 months unless directed by a doctor
• children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

OTHER SAFETY INFORMATION

Other information

• read the directions and warnings before use
• keep the carton. It contains important information
• store at 20-25°C (68-77°F); keep product out of high heat and moisture
• store in the original package

Inactive ingredients

acetone, alcohol, amino methacrylate copolymer, ascorbic acid, benzyl alcohol, cetyl alcohol, colloidal silicon dioxide, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, flavor, hypromellose, hypromellose phthalate, isopropyl alcohol, mannitol, microcrystalline cellulose, modified starch, polysorbate 80, pregelatinized starch, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments? 1-800-XXX-XXXX:

Weekdays XXX AM to XXX PM EST

Tips for Managing Heartburn

• Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
• Eat slowly and do not eat big meals.
• Do not eat late at night or just before bedtime.
• Do not lie flat or bend over soon after eating.
• Raise the head of your bed.
• Wear loose-fitting clothing around your stomach.
• If you are overweight, lose weight.
• If you smoke, quit smoking.

PRINCIPAL DISPLAY PANEL

NDC: 64239-112-02

MELTechTM

Melts in Your Mouth

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

PRINCIPAL DISPLAY PANEL

NDC: 64239-112-03

MELTechTM

Melts in Your Mouth

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

28 TABLETS

Two 14-day courses of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

PRINCIPAL DISPLAY PANEL

NDC: 64239-112-04

MELTechTM

Melts in Your Mouth

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

42 TABLETS

Three 14-day courses of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

PRINCIPAL DISPLAY PANEL

NDC: 64239-112-05

MELTechTM

Melts in Your Mouth 

FREE SAMPLE

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

2 TABLETS

First 2 doses of a 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

PRINCIPAL DISPLAY PANEL

NDC: 64239-112-07

MELTechTM

Melts in Your Mouth 

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

PRINCIPAL DISPLAY PANEL

NDC: 64239-112-08

MELTechTM

Melts in Your Mouth 

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

28 TABLETS

Two 14-day courses of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

PRINCIPAL DISPLAY PANEL

NDC: 64239-112-09

MELTechTM

Melts in Your Mouth 

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

42 TABLETS

Three 14-day courses of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

PRINCIPAL DISPLAY PANEL

NDC: 64239-112-10

MELTechTM

Melts in Your Mouth 

FREE SAMPLE

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts in your mouth

Dissolves without water

2 TABLETS

First 2 doses of a 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size

INGREDIENTS AND APPEARANCE

ESOMEPRAZOLE 
esomeprazole tablet, orally disintegrating, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64239-112
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Esomeprazole (UNII: N3PA6559FT) (ESOMEPRAZOLE - UNII:N3PA6559FT)	Esomeprazole	20 mg

Inactive Ingredients
Ingredient Name	Strength
ACETONE (UNII: 1364PS73AF)
ALCOHOL (UNII: 3K9958V90M)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 170 CST) (UNII: 8LDD2V82F5)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEARATE (UNII: QU7E2XA9TG)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
SORBITOL (UNII: 506T60A25R)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	blue	Score	no score
Shape	ROUND	Size	11mm
Flavor	RASPBERRY (Wildberry)	Imprint Code	20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64239-112-07	2 in 1 CARTON	04/12/2024
1		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 64239-112-08	2 in 1 CARTON	04/12/2024
2		2 in 1 CARTON
2		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 64239-112-09	3 in 1 CARTON	04/12/2024
3		2 in 1 CARTON
3		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 64239-112-10	1 in 1 CARTON	04/12/2024
4		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 64239-112-02	2 in 1 CARTON	04/12/2024
5		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 64239-112-03	2 in 1 CARTON	04/12/2024
6		2 in 1 CARTON
6		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 64239-112-04	3 in 1 CARTON	04/12/2024
7		2 in 1 CARTON
7		7 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC: 64239-112-05	1 in 1 CARTON	04/12/2024
8		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA214278	04/12/2024

Labeler - Dexcel Pharma Technologies Ltd (533597626)

Establishment
Name	Address	ID/FEI	Business Operations
Dexcel Pharma Technologies Ltd		533597626	manufacture(64239-112)